A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

NCT05836324
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
570
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Lead sponsor
Incyte Corporation
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Start date
2023-07-24
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Number of sites
39
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Summary
To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.
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Short title
A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
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Official title
A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2029-05-03
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First posted
2023-05-01
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Registry last updated
2026-07-23
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Primary completion date
2029-05-03
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Start date
2023-07-24
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Participants
570
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Participant count basis
Estimated
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Planned participants
570
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Protocol amendments
5
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Number of sites
39
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Registry sponsor category
Industry
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Lead sponsor
Incyte Corporation
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05836324
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ClinicalTrials.gov ID
NCT05836324
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Dose Limiting Toxicities (DLTs)

    Timeframe: Up to 28 days

  2. Treatment Emerging Adverse Events (TEAEs)

    Timeframe: Up to 2 years

  3. TEAEs leading to dose modification or discontinuation

    Timeframe: Up to 2 years

  1. Objective response Rate

    Timeframe: 2 years

  2. Disease Control Rate

    Timeframe: 2 years

  3. Duration of Response

    Timeframe: 2 years

  4. Pharmacokinetics Parameter : Cmax of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  5. Pharmacokinetics Parameter : Tmax of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  6. Pharmacokinetics Parameter : Cmin of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  7. Pharmacokinetics Parameter : AUC(0-t) of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  8. Pharmacokinetics Parameter : AUC 0-∞ of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  9. Pharmacokinetics Parameter : CL of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  10. Pharmacokinetics Parameter : Vz of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

  11. Pharmacokinetics Parameter : t1/2 of INCA33890

    Timeframe: Pre dose - Day 1 of Cycle 1(C1D1)- 28 (each cycle is 28 days), Day 15 of Cycle 1-3; 10min and 4hrs Post dose(PD) - C1D1,C1D4, 24hrs PD C1D2, any time PD Day 4, 8, 22, of Cycle 1, and any time during 30 day Follow Up

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • ≥18 years old
  • Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
  • Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study.
  • ECOG performance status score of 0 or 1.
  • Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts.
  • Presence of measurable disease according to RECIST v1.1.

  • Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years.

  • Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.

  • Has active autoimmune disease requiring systemic immunosuppression with corticosteroids.

  • Brain or CNS metastases untreated or that have progressed.

  • History of organ transplant, including allogeneic stem cell transplantation.

  • History of clinically significant or uncontrolled cardiac disease.

  • Active HBV, active HCV, or HIV positive.

  • Is on chronic systemic steroids (> 10 mg/day of prednisone or equivalent).

  • Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment

  • Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.

  • Significant concurrent, uncontrolled medical condition, eg:

    • Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance or history of myocarditis.
    • Gastrointestinal: Any bowel obstruction within 60 days prior to C1D1.

  • Participants with adequate laboratory values within the protocol defined ranges.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Sources for eligibility
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  • The Angeles Clinic and Research InstituteLos Angeles, United StatesRecruiting
  • Valkyrie Clinical TrialsLos Angeles, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • Cancer and Hematology Centers of Western Michigan-Start MidwestGrand Rapids, United StatesRecruiting
  • Hackensack University Medical CenterHackensack, United StatesRecruiting
  • Nyu Langone Health - Long Island HospitalMineola, United StatesRecruiting
  • Laura and Isaac Perlmutter Cancer CenterNew York, United StatesRecruiting
  • University of PennsylvaniaPhiladelphia, United StatesRecruiting
  • Lifespan Cancer Research InstituteProvidence, United StatesRecruiting
  • University of Texas Md Anderson Cancer CenterHouston, United StatesRecruiting
  • South Texas Accelerated Research TherapeuticsSan Antonio, United StatesRecruiting
  • Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaNot yet recruiting
  • Peking University People'S HospitalBeijing, ChinaNot yet recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine (Fahzu)Hangzhou, ChinaNot yet recruiting
  • Rigshospitalet Uni of Hospital of CopenhagenCopenhagen, DenmarkRecruiting
  • Herlev Og Gentofte HospitalHerlev, DenmarkRecruiting
  • Odense University HospitalOdense C, DenmarkRecruiting
  • Vejle HospitalVejle, DenmarkRecruiting
  • Centre Leon BerardLyon, FranceRecruiting
  • Institut Gustave RoussyVillejuif, FranceRecruiting
  • Fondazione Irccs Istituto Nazionale Dei TumoriMilan, ItalyRecruiting
  • Irccs Istituto Clinico HumanitasRozzano, ItalyRecruiting
  • Centro Ricerche Cliniche Di VeronaVerona, ItalyRecruiting
  • Kansai Medical University HospitalHirakata, JapanRecruiting
  • National Cancer Center HospitalTokyo, JapanRecruiting

And 14 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2022-502456-31-00
Sources for references
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Targets (2)